—
Tag: legislation
President of Slovak republic, Ivan Gašparovič, has signed the amendment to the act on pharmaceuticals, which tightens the supervision over human pharmaceuticals. Amendment to the act approved in July by members of Parliament also implements the changes by the market supervision and penalties by failing to comply with the provisions of the act. It also tightens the requirements for all subjects treating with human pharmaceuticals, especially the holders of human pharmaceutical registration.
Ministry of Health wants to prevent the human blood or plasma to be collected and exported without processing as a starting material for preparation of transfusion pharmaceuticals for industrial use in pharmaceutical industry. Only residential healthcare institutions and national transfusion service would thus be able to obtain the permission for preparing of transfusion pharmaceuticals. Ministry is planning to enforce this change through the amendment to the act on pharmaceuticals and medical devices.
Ministry of Health will significantly not prohibit the extension of the networks of pharmacies. Although Minister in the prepared amendment to the act on pharmaceuticals proposes how many pharmacies may be owned by one person or company, but does not specify that the owner should only be a pharmacist. Slovak Medical Chamber would, according to its vice president, prefer the model that works in most of EU countries, that a pharmacist may own only one pharmacy.
Prohibition of loyalty systems in public pharmacies already has its legal version. Ministry of Health has submitted to public comments the material, which proposes the prohibition of providing financial or non-financial benefits and donations by the pharmaceuticals, dietary supplements and medical devices available on prescription. Holder of the provision for providing of pharmaceutical care will not be able to provide such benefits personally or through other persons.
Associations representing all key pharmaceutical producers and distributors have participated on the professional discussion on pharmaceutical legislation. They have submitted to Ministry of Health their proposals for adjustment of the acts influencing the pharmaceutical and medical devices market. In their proposals they are mainly dealing with unsolved issues of contradiction of several laws, as well as with the facto non-enforcement of some legal standards, overall market flexibility or strengthening of patient rights.
Union believes that health insurance sector with several insurance companies is more effective than system with one insurance company with no competition. Board member of Union, Boris Masloviec, specified that shareholder of the insurance company – Dutch health insurance company Achmea is analysing the steps of Slovak Government and has already informed Government on its displeasure and disapproval. According to general director of Union, Roman Polák, the Government's argument for creation of one insurance company which relies on profits from health insurance is irrelevant.
Forcing nurses to sign the amendments to the contracts or new contracts, which ascribe them the professional activities out of their classification, is unethical and in conflict with the Directive of EU Parliament and Committee on Recognition of Professional Classifications. This is stated in the supporting statement for Slovak nurses made by General Secretary of the European Federation of Nurses, Paul de Raeve. Such practices for circumventing of the act on minimum wage claims of nurses should be according to him monitored by European Union, including the EU Agency for Fundamental Rights.
Members of Parliament now put the Slovak act on pharmaceuticals from December 2010 into accordance with the Direction of EU Parliament and EU Committee. Changes ensure the closer supervision over the pharmaceuticals for people especially by tightening of requests for the pharmaceutical registration holders – pharmaceutical companies. For the treatment with unregistered pharmaceutical the prescribing doctor will assume the responsibility. Patient has to agree in writing with this treatment and the approval will be a part of his/her documentation.
Government has approved the intention to create one health insurance company managed by the state. The change should occur with or without the approval of the shareholders of private health insurance companies. Detailed proposal of the process is about to be developed by the Ministry of Health by the end of September. According to the Prime Minister, Robert Fico, the new system could become operational from January 2014. Ministry of Health for now considers three various ways how to implement its plan.
Ministry of Health proposes to include into the terminal network of hospitals totaly 34 hospitals and 2 medical institutions. Concept of terminal network of hospitals in Slovakia will be renewed from October. Network should include 8 institutions from Bratislava region, 7 from Košice region and 6 from Banská Bystrica region. Nitra and Žilina region will have both 4 institutions included, Prešov region will have 3 and Trnava and Trenčín 2 institutions included.
